Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.
Week in Review Highlight of the Week:
This week, the Senate Finance Committee voted along party lines to advance RFK Jr.’s nomination to be HHS Secretary to the full Senate, while President Trump imposed tariffs on imports from China but delayed tariffs on imports from Canada and Mexico.
I. Regulations, Notices & Guidance
Note: For many Executive Office of the President (EOP) actions, the stated day reflects when the action was noticed to the Federal Register, not when it was first released by the White House.
- On February 3, 2025, the Centers for Medicare & Medicaid Services (CMS) released a notice entitled, Announcement of the Advisory Panel on Outreach and Education (APOE) Virtual Meeting; Cancellation of the February 6, 2025, Virtual Meeting. This notice announces the cancellation of the February 6, 2025, virtual public meeting of the APOE that was announced in the January 10, 2025, Federal Register (90 FR 2003 through 2005). CMS will publish a notice in the Federal Register announcing the date on which the next meeting of the APOE will take place no less than 15 calendar days before the meeting date. The meeting will be open to the public in accordance with the Federal Advisory Committee Act (FACA).
- On February 6, 2025, EOP released an executive order (EO) entitled Unleashing Prosperity Through Deregulation. Among other provisions, the EO directs that whenever an executive department or agency publicly proposes for notice and comment or otherwise promulgates a new regulation, it must identify at least 10 existing regulations to be repealed.
- On February 6, 2025, EOP released an EO entitled, Imposing Duties to Address the Situation at our Southern Border. This EO generally imposes additional ad valorem tariffs on certain articles imported from Mexico.
- On February 7, 2025, EOP released an EO entitled Progress on the Situation at Our Southern Border. This EO delays the imposition of additional ad valorem tariffs on articles from Mexico.
- On February 6, 2025, EOP released an EO entitled, Imposing Duties to Address the Flow of Illicit Drugs Across our Northern Border. This EO generally imposes additional ad valorem tariffs on certain articles imported from Canada.
- On February 7, 2025, EOP released an EO entitled Progress on the Situation at Our Northern Border. This EO delays the imposition of additional ad valorem tariffs on articles from Canada.
- On February 6, 2025, EOP released an EO entitled, Imposing Duties to Address the Synthetic Opioid Supply Chain in the People’s Republic of China. This EO generally imposes additional ad valorem tariffs on certain articles imported from China.
Event Notices—NOTE: Due to an HHS communications freeze, many of these meetings have been cancelled or postponed. We are continuing to monitor.
February 10, 2025: NIH announced a meeting of the National Advisory Council for Human Genome Research. This is a virtual meeting open to the public.
February 11-12, 2025: The Centers for Disease Control and Prevention (CDC) announced a meeting of the Association of Public Health Laboratories (APHL) entitled, Establishing a Road Map for Accelerated Diagnosis and Treatment of HCV Infection in the United States. This is a virtual meeting open to the public.
February 13-14, 2025: HRSA announced a meeting of the Advisory Committee on Heritable Disorders in Newborns and Children. This is a virtual meeting open to the public.
February 25, 2025: CDC announced a meeting of the Advisory Board on Radiation and Worker Health. This is a hybrid meeting open to the public.
February 25, 2025: FDA announced a public workshop entitled, Cell Therapies and Tissue-Based Products: A Public Workshop on Generating Scientific Evidence to Facilitate Development. This is a virtual workshop open to the public.
February 26-28, 2025: CDC announced a meeting of the Advisory Committee on Immunization Practices (ACIP). This is a virtual meeting open to the public.
March 5, 2025: The Department of Veterans Affairs (VA) announced a meeting of the Rehabilitation Research and Development Service (RR&D) Scientific Merit Review Board. This is a virtual meeting, partially open to the public.
March 5-6, 2025: HRSA announced a meeting of the National Advisory Council on Nurse Education and Practice (NACNEP). This is a hybrid meeting open to the public.
March 27-28, 2025: HRSA announced a meeting of the Advisory Committee on Training in Primary Care Medicine and Dentistry (ACTPCMD). This is a hybrid meeting open to the public.
March 27-28, 2025: FDA announced a public workshop entitled, Optimizing Pregnancy Registries. This is an in-person workshop open to the public.
April 3, 2025: NIH announced a meeting of the Board of Scientific Counselors for the National Institute of Diabetes and Digestive and Kidney Diseases. This is a hybrid meeting open to the public.
April 10-11, 2025: HRSA announced a meeting of the Council on Graduate Medical Education (COGME). This is a hybrid meeting open to the public.
April 30, 2025: NIH announced a meeting of the National Library of Medicine Board of Scientific Counselors. This is a hybrid meeting with some sessions open to the public.
May 14, 2025: HRSA announced a meeting of the National Advisory Council on Nurse Education and Practice (NACNEP). This is a hybrid meeting open to the public.
May 14, 2025: NIH announced a meeting of the National Advisory Council on Aging. This is an in-person meeting with one session open to the public.
June 3-4, 2025: FDA announced a public workshop entitled, Fiscal Year (FY) 2025 Generic Drug Science and Research Initiatives Workshop. This is a hybrid workshop open to the public.
August 6-7, 2025: HRSA announced a meeting of the National Advisory Council on Nurse Education and Practice (NACNEP). This is a hybrid meeting open to the public.
August 8, 2025: HRSA announced a meeting of the Advisory Committee on Training in Primary Care Medicine and Dentistry (ACTPCMD). This is a hybrid meeting open to the public.
September 11-12, 2025: HRSA announced a meeting of the COGME. This is a hybrid meeting open to the public.
December 4-5, 2025: HRSA announced a meeting of the National Advisory Council on Nurse Education and Practice (NACNEP). This is a hybrid meeting open to the public.
II. Hearings & Markups
- On February 4, 2025, the Senate Committee on the Judiciary held a hearing entitled, Hearings to examine the poisoning of America, focusing on fentanyl, its analogues, and the need for permanent class scheduling. Witnesses included: Jaime Puerta, President and Co-Founder of Victims of Illicit Drugs (“V.O.I.D.”) and Co-Chair of Project Facing Fentanyl; Bridgette Norring, Survivor Parent and Founder, Devin J. Norring Foundation; Timothy W. Westlake, M.D., FFSMB, FACEP, Emergency Physician, ProHealth Oconomowoc Memorial Hospital; Cecilia Farfán, Ph.D., Affiliated Researcher, Institute on Global Conflict and Cooperation, University of California San Diego; and Donald Barnes, Vice President of Homeland Security, Major County Sheriffs of America and Sheriff-Coroner of Orange County, California.
- On February 6, 2025, the House Committee on Energy and Commerce’s Subcommittee on Health held a hearing entitled, Combatting Existing and Emerging Illicit Drug Threats. Witnesses included: Sheriff Michael Bouchard, Vice President of Government Affairs, Major County Sheriffs Association; Mr. Raymond Cullen, Family Advocate; Dr. Timothy Westlake, MD, FFSMB, FACEP, Emergency Medicine Physician, ProHealth Care Oconomowoc Memorial Hospital; Ms. Regina LaBelle, JD, Professor and Director, Master of Science in Addiction Policy and Practice, Georgetown University; Dr. Deepa Camenga, MD, MHS, FAAP, Chair, Committee on Substance Use and Prevention, American Academy of Pediatrics.
III. Reports, Studies, & Analyses
- On February 6, 2025, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a report entitled, Medicare Improperly Paid Suppliers for Intermittent Urinary Catheters. The audit examined Medicare payments for catheters from July 2021 through June 2022 and found that approximately $35.1 million was improperly paid, with enrollees responsible for $8.8 million in associated coinsurance. Errors included insufficient medical documentation for curved-tip catheters and sterile catheter kits, as well as supplier noncompliance with Medicare requirements for refills, proof of delivery, and written orders. Additionally, OIG flagged a sharp rise in claims for curved-tip catheters provided to female enrollees in 2023 as a potential indicator of further improper billing. OIG recommended that CMS recover $11,399 in identified overpayments, conduct additional medical reviews that could have saved Medicare an estimated $35.1 million, and enhance supplier education on documentation requirements. CMS concurred with all recommendations except one related to the 60-day rule, which was removed from the final report. CMS has already taken corrective action against 15 suppliers based on OIG’s findings.
- On February 6, 2025, the Government Accountability Office (GAO) released a report entitled, Disaster Contracting: Opportunities Exist for FEMA to Improve Oversight. The report examines the Federal Emergency Management Agency’s (FEMA’s) use of contracts for disaster response and recovery from FYs 2018 through 2023, during which it obligated over $10 billion on contracts, primarily for services such as housing inspections. GAO found that while FEMA took steps to oversee contractor performance, it did not consistently document oversight activities, making it difficult to assess whether goods and services met contract requirements. Additionally, some FEMA staff conducting oversight lacked the required certification or authorization, increasing the risk of unqualified personnel assessing contract performance. GAO issued seven recommendations to address these concerns, including ensuring FEMA oversight staff are properly certified and authorized, improving documentation of contractor performance, and incorporating risk factors into staffing models. The Department of Homeland Security (DHS) and FEMA concurred with the recommendations and outlined steps to address them, such as conducting quarterly reviews to ensure compliance. The report underscores the need for stronger oversight and workforce planning to enhance FEMA’s contract management and disaster response capabilities.
- On February 7, 2025, the Kaiser Family Foundation (KFF) released an analysis entitled, How Much Global Health Funding Goes Through USAID?. The report found that in FY 2023, the United States Agency for International Development (USAID) managed 73 percent of U.S. bilateral global health assistance, or $6.2 billion of the total $8.5 billion. HHS handled 22 percent ($1.9 billion), primarily through CDC, while the State Department and other agencies accounted for the rest. For the President’s Emergency Plan for AIDS Relief (PEPFAR), USAID implemented 60 percent of bilateral HIV/AIDS funding ($2.5 billion), with HHS managing 37 percent ($1.6 billion). USAID played an even larger role in certain sectors, overseeing 100 percent of maternal and child health, tuberculosis, and global health security funding, and nearly all family planning and malaria programs. The report comes amid uncertainty about USAID’s future following an executive order from President Donald Trump pausing new foreign aid obligations and calling for a review of all assistance programs. If USAID’s role is reduced or eliminated, the report warns of potential disruptions to global health service delivery and outcomes.
IV. Other Health Policy News
- On February 3, 2025, Senate Finance Committee members including Chairman Mike Crapo (R-ID), Ranking Member Ron Wyden (D-OR), Senator Michael Bennet (D-CO), and Senator Tim Scott (R-SC), reintroduced the bipartisan Medicare Multi-Cancer Early Detection (MCED) Screening Coverage Act. The bill would provide Medicare beneficiaries with access to advanced tests capable of detecting multiple types of cancer before symptoms appear. It would establish a coverage pathway under Medicare for certain U.S. Food and Drug Administration (FDA)-approved MCED tests, which can screen for a broad range of cancers, many of which currently lack effective screening options. The bill would also authorize CMS to provide coverage for these tests, while maintaining CMS’s authority to determine coverage parameters based on evidence. Additionally, the bill would specify that these new diagnostic technologies would supplement, not replace, existing screenings and would not impact current coverage or cost-sharing requirements. A companion bill, H.R. 842, was also introduced in the U.S. House of Representatives. The text of the Senate bill is available here.
- On February 4, 2025, the Senate Finance Committee voted 14-13 along party lines to advance Robert F. Kennedy, Jr.’s nomination for HHS Secretary. All Republican members supported the nomination, while Democrats opposed it. Those backing Mr. Kennedy, including Senator Bill Cassidy (R-LA), emphasized his commitment to improving nutrition policies and enhancing agency transparency. Senator Cassidy, who had previously expressed reservations about the nomination, ultimately voted in favor after receiving assurances from Mr. Kennedy regarding collaboration with Congress and his office throughout his tenure. Additionally, Kennedy committed to maintaining current vaccine information on agency websites, specifically pledging not to remove statements from CDC affirming that vaccines do not cause autism. Mr. Kennedy also assured that he would work within existing vaccine approval and safety monitoring systems rather than creating parallel structures. Democrats on the committee strongly opposed the nomination, citing concerns about Mr. Kennedy’s past statements on vaccines and public health policies. They warned that his views could undermine trust in federal health institutions and questioned his suitability to lead HHS. The nomination now moves to the full Senate, where Republicans hold a majority. A confirmation vote is expected in the coming days.
- On February 4, 2025, Senators Chuck Grassley (R-IA) and Peter Welch (D-VT) introduced the bipartisan Rural Hospital Support Act to address the financial challenges facing rural hospitals. The bill seeks to extend and modernize key Medicare programs that help prevent rural hospital closures and ensure continued access to essential care in rural communities. The proposed legislation would permanently extend the Medicare-Dependent Hospital (MDH) program and the Low-Volume Hospital (LVH) program, both of which provide crucial financial support to rural hospitals. Additionally, it would update the rebasing year for Sole Community Hospitals (SCH) and MDHs to more accurately reflect current cost trends. The MDH and LVH programs are set to expire on March 31, 2025, without further congressional action. The text of the bill is available here.
- On February 4, 2025, Representatives Angie Craig (D-MN), Andrew Garbarino (R-NY), Kim Schrier (D-WA), and David Valadao (R-CA) introduced the bipartisan Health Care Workforce Innovation Act. This legislation aims to address healthcare staffing shortages and improve access to care, particularly in rural and underserved communities. By establishing new partnerships between Community Health Centers (CHCs), Rural Health Clinics (RHCs), and educational institutions, the bill would create pathways for young people and early-career health professionals to enter and advance in the healthcare sector. The bill would establish a federal grant program through HRSA to support these community-driven training models. It would also incentivize long-term careers in the health field through career laddering programs. The grants, which could total up to $2.5 million, would support projects aimed at expanding the health workforce, developing preceptorship programs, and ensuring access to essential health services in communities across the country. The bill, which has received bipartisan support, is seen as a critical step in addressing workforce shortages and improving healthcare delivery in rural areas. The text of the bill is available here.
- On February 5, 2025, House Democratic health leaders, including Energy and Commerce Committee Ranking Member Frank Pallone, Jr. (D-NJ), Ways and Means Committee Ranking Member Richard Neal (D-MA), and Education and Workforce Committee Ranking Member Bobby Scott (D-VA), called on GAO to actively monitor the Medicare Drug Price Negotiation Program. The leaders urged the GAO to ensure that the Trump Administration upholds its legal obligation to negotiate lower prescription drug prices for seniors. In a letter to the Comptroller General, the lawmakers emphasized the importance of reducing prescription drug costs and saving seniors money. They requested that the GAO examine the ongoing implementation of the program to ensure it continues to meet its objectives of lowering drug prices, reducing federal spending, and benefiting Medicare beneficiaries. The letter follows recent testimony by Robert F. Kennedy, Jr., President Trump’s nominee for HHS Secretary, where he declined to commit to fully implementing the program. The Inflation Reduction Act of 2022 (IRA), which established the Medicare Drug Price Negotiation Program, directed GAO to oversee the law’s provisions, including the negotiation process for the first set of drugs scheduled for price reductions starting in 2026. The lawmakers requested GAO review CMS’s negotiation process and internal controls; its efforts to meet statutory deadlines; and its collaboration with other agencies. They also asked for an examination of how CMS utilized manufacturer-specific data and input from the public to determine fair pricing. The letter highlights that GAO’s findings will be critical to ensuring that the Medicare Drug Price Negotiation Program continues to deliver on its promise to lower drug prices for seniors. A press release with more information is available here. The letter to the Comptroller General is available here.
View our Health Care Legislative & Public Policy team.
Did you miss a week? Browse our Health Care Week in Review archive.